RECRUITING

Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy

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Conditions

Recurrent Glioblastoma, IDH-WildtypeRecurrent Astrocytoma, IDH-Mutant, Grade 4Astrocytoma, Grade IV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial tests the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) in treating patients with glioblastoma or astrocytoma that has come back (recurrent) who are undergoing brain surgery (craniotomy). Glioblastoma is the most common and most aggressive form of primary and malignant tumor of the brain. Currently, the standard of care for this disease includes surgical resection, followed by radiation with chemotherapy and tumor treating fields. Despite this aggressive therapy, the survival after finishing treatment remains low and the disease often reoccurs. Unfortunately, the available therapy options for recurrent glioblastoma are minimal and do not have a great effect on survival. AMSCs are found in body fat and when separated from the fat, are delivered into the surgical cavity at the time of surgery. When in direct contact with tumor cells, AMSCs affect tumor growth, residual tumor cell death, and chemotherapy resistance. The use of AMSCs delivered locally into the surgical cavity of recurrent glioblastoma during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.

Official Title

Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma

Quick Facts

Study Start:2023-06-16
Study Completion:2025-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05789394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants \>= 18 years \< 65 years of age
  2. * Karnofsky Performance Scale (KPS) \>= 60
  3. * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
  4. * Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system that show recurrence at the same location, who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor
  5. * Patients have undergone previous standard of care as outlined by Stupp et al. (2004) which include maximal safe resection followed by concomitant radiation therapy and chemotherapy with oral temozolomide
  6. * There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria
  7. * Serum creatinine and urea \<= 2 times the upper limit of normal (=\< 3 weeks prior to registration)
  8. * Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\< 3 times the upper limit of normal, and bilirubin =\< 2.5 mg/dL (=\< 3 weeks prior to registration)
  9. * Prothrombin time =\< 1.5 times upper limit of normal (=\< 3 weeks prior to registration)
  10. * International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 times the upper limit of normal (=\< 3 weeks prior to registration)
  11. * Hemoglobin \>= 9 g/dL (=\< 3 weeks prior to registration)
  12. * Platelets \>= 100 x 10\^9/L (=\< 3 weeks prior to registration)
  13. * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (=\< 3 weeks prior to registration)
  14. * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  15. * Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol
  16. * Willingness to provide mandatory blood specimens for correlative research
  17. * Willingness to provide mandatory tissue specimens for correlative research
  18. * Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research
  1. * Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention
  2. * Tumors located in the brain stem, midbrain, or thalamus
  3. * Previous treatment with bevacizumab
  4. * Radiographic evidence of leptomeningeal disease

Contacts and Locations

Principal Investigator

Alfredo Quinones-Hinojosa, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Alfredo Quinones-Hinojosa, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-16
Study Completion Date2025-07-24

Study Record Updates

Study Start Date2023-06-16
Study Completion Date2025-07-24

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Glioblastoma, IDH-Wildtype
  • Recurrent Astrocytoma, IDH-Mutant, Grade 4
  • Astrocytoma, Grade IV